lnline Persuader- PedFuse Pedicle Screw System recall
lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164
Why was lnline Persuader- PedFuse Pedicle Screw System recalled?
A crack may develop in the handle to the Inline Persuader, which may progress if the user continues to use the affected instrument.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot/Serial Numbers: 06440-0000, 06441-0000, AG24
- Product
- lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164
- Recalling firm
- SpineFrontier, Inc.
- Quantity
- 4 devices
- Distribution
- Nationwide Distribution including TX, OH, VA, and Washington, DC.
- Recall date
- January 21, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)